Congenital HypothyroidismIpoMetNCT07126353
Metabolic Risk Assessment in Prepubertal Children With Congenital Hypothyroidism
An observational study of Congenital Hypothyroidism and Metabolic Syndrome, run by Buzzi Children's Hospital at 1 site in Italy.
Trial summary
We propose a multicenter prospective study to define the prevalence and severity score of metabolic syndrome in a prepubertal pediatric cohort with congenital hypothyroidism, compared to a healthy and normal-weight pediatric population. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Hypothyroidism, Metabolic Syndrome
- What is being tested?
- prospective observational study (clinical, hormonal and auxological data)
- How many people
- 170 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2025to Oct 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: We enrolled patients affected by permanent congenital hypothyroidism in prepubertal age and healthy childrens in prepubertal age to compare them with each other.
Who may be able to join
- Pubertal stage Tanner 1
- Permanent congenital hypothyroidism
- All ethnic groups
- Informed consent signature
Who cannot join
- Age< 5 years
- Pubertal stage Tanner 2-5
- Transient congenital hypothyroidism or other type of hypothyroidism
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Buzzi Children's Hospital
Milan, 20154
Valeria Calcaterra, Prof, MD, 00390263635321, valeria.calcaterra@unipv.it
About this study
Official title: Metabolic Risk Assessment in Prepubertal Children With Congenital Hypothyroidism (IpoMet)
We propose a multicenter prospective study to define the prevalence and severity score of metabolic syndrome in a prepubertal pediatric cohort with congenital hypothyroidism, compared to a healthy and normal-weight pediatric population. These data will help to define whether hypothyroidism can be considered a risk factor for the metabolic health of the pediatric population. The possible identification of an at-risk metabolic profile will provide useful information to optimize the diagnostic and monitoring pathway for affected children.
Read the detailed description
Primary congenital hypothyroidism is the most common endocrine disorder in childhood and can present in either a permanent or transient form. Prolonged thyroid hormone deficiency can cause widespread damage affecting multiple organs and systems. Exposure to thyroid hormone deficiency during fetal and/or neonatal life has particularly severe consequences on the central nervous system, leading to neurocognitive delay. Appropriate and timely hormone replacement therapy (L-thyroxine) can prevent such outcomes, provided it is initiated early.
Thyroid hormones play a crucial role not only in growth and organ development but also in metabolic homeostasis. Thyroid function lies at the crossroads of multiple metabolic pathways. They have multiple effects on glucose and lipid metabolism, specifically by increasing glucose levels, fatty acid oxidation in muscle and liver, and lipolysis in adipose tissue. They also contribute to blood pressure regulation, thereby influencing the prevalence of metabolic syndrome, which is itself a key predictor of type 2 diabetes, cardiovascular diseases, and neurodegenerative conditions.Thyroid function plays a central regulatory role at the intersection of key metabolic pathways. Although, the role of thyroid hormones in metabolic processes is well established, and a bidirectional relationship between metabolic dysfunction and thyroid hypofunction has been reported in the adult population, data on metabolic risk in pediatric patients with congenital hypothyroidism are currently lacking.
The primary aim of this multicenter project is to assess the prevalence of metabolic syndrome in patients with congenital hypothyroidism and to determine whether this population presents a higher metabolic risk profile compared to the general population. As secondary objectives, this prospective study aims to:
- Define the prevalence and severity score of metabolic syndrome in a prepubertal pediatric cohort with congenital hypothyroidism, compared to a pediatric population with obesity.
- Evaluate the correlations between individual metabolic dysfunction parameters and the clinical and hormonal profile (including thyroid hormone levels and thyroid hormone sensitivity indices).
- Assess the correlations between the metabolic profile and renal function.
- Assess the correlations between the hormonal profile and renal function. To achieve these objectives, auxological parameters, vital signs (including blood pressure and heart rate), and metabolic profile data (glucose and lipid profiles, renal function, and hormonal status - FT3, FT4, TSH and thyroid hormone resistence indices TSHI, TT4RI, TT3RI, TFQI, PTFQI) will be collected for each enrolled subject. These parameters will be evaluated on peripheral blood samples collected during routine blood monitoring already scheduled according to established follow up. The potential presence of metabolic syndrome will be evaluated in each enrolled patient. The severity of the metabolic disorder will be evaluated using the Metabolic Score (MetS).
Data analysis will be performed using the statistical packages R 4.0.5 (R Core Team, 2021) and STATA (version 15.1, 2017, Stata Corporation, College Station, Texas, USA).
- Conditions
- Congenital Hypothyroidism, Metabolic Syndrome
- Being tested
- prospective observational study (clinical, hormonal and auxological data)
- Keywords
- Congenital hypothyroidism, metabolic syndrome, Obesity
- Medical subject headings
- Congenital Hypothyroidism, Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prospective observational study (clinical, hormonal and auxological data)Other
We collect clinical, hormonal and auxological data and compare them between the two groups.
| Study group | Role | What they receive |
|---|---|---|
| Permanent congenital hypothyroidism | 170 patients in prepubertal age. Receives: Other: prospective observational study (clinical, hormonal and auxological data) | |
| Healthy childrens normal weight | 170 childrens in prepubertal age. Receives: Other: prospective observational study (clinical, hormonal and auxological data) | |
| Healthy childrens overweight/obese | 170 patients in prepubertal age Receives: Other: prospective observational study (clinical, hormonal and auxological data) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic syndrome (MS)
Presence of at least 3 of the following parameters:
- BMI z-score ≥ 2 and/or waist-to-height ratio (WHtR) > 0.5
- Fasting blood glucose ≥ 100 mg/dL and/or TryG index ≥ 7.88
- Total cholesterol ≥ 200 mg/dL
- HDL cholesterol < 40 mg/dL and/or LDL cholesterol ≥ 130 mg/dL
- Triglycerides (TG) ≥ 100 mg/dL for ages 0-9 years; ≥ 130 mg/dL for ages >10 years
- Systolic and/or diastolic blood pressure (SBP and/or DBP) ≥ 90th percentile for age and sex
Measured: At the time of enrollment
Metabolic score (MeTs)
Males MetS z-score = -4.931 + 0.2804 * BMI z-score - 0.0257 * HDL + 0.0189 * SBP + 0.6240 * log(triglycerides) + 0.0140 * fasting glucose
Females MetS z-score = -4.3757 + 0.4849 * BMI z-score - 0.0176 * HDL-C + 0.0257 * SBP + 0.3172 * log(triglycerides) + 0.0083 * fasting glucose
Measured: At the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Congenital HypothyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Buzzi Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University, IRCCS Ospedale San Raffaele, Policlinico di Bari Giovanni XXIII, Azienda Ospedaliero Universitaria Policlinico Modena, Azienda Ospedaliero-Universitaria di Parma, Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna, Azienda Ospedaliera Sant'Anna, University Hospital Perugia, University of L'Aquila, Clinica Pediatrica Università di Novara, Santobono-Pausilpon Hospital, Azienda Ospedaliera Universitaria Policlinico "G. Martino", IRCCS Azienda Ospedaliero-Universitaria di Bologna, University Hospital of Ancona
- Responsible party
- Principal investigator, Valeria Calcaterra, Buzzi Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126353
- Sponsor's protocol ID
- CET 503-2024
- Acronym
- IpoMet
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jostel A, Ryder WD, Shalet SM. The use of thyroid function tests in the diagnosis of hypopituitarism: definition and evaluation of the TSH Index. Clin Endocrinol (Oxf). 2009 Oct;71(4):529-34. doi: 10.1111/j.1365-2265.2009.03534.x. Epub 2009 Feb 18.
PubMed 19226261Iwamoto Y, Kimura T, Tatsumi F, Sugisaki T, Kubo M, Nakao E, Dan K, Wamata R, Iwamoto H, Takahashi K, Sanada J, Fushimi Y, Katakura Y, Shimoda M, Nakanishi S, Mune T, Kaku K, Kaneto H. Effect of Hyperglycemia-Related Acute Metabolic Disturbance on Thyroid Function Parameters in Adults. Front Endocrinol (Lausanne). 2022 May 12;13:869869. doi: 10.3389/fendo.2022.869869. eCollection 2022.
PubMed 35634497Dietrich JW, Landgrafe-Mende G, Wiora E, Chatzitomaris A, Klein HH, Midgley JE, Hoermann R. Calculated Parameters of Thyroid Homeostasis: Emerging Tools for Differential Diagnosis and Clinical Research. Front Endocrinol (Lausanne). 2016 Jun 9;7:57. doi: 10.3389/fendo.2016.00057. eCollection 2016.
PubMed 27375554Laclaustra M, Moreno-Franco B, Lou-Bonafonte JM, Mateo-Gallego R, Casasnovas JA, Guallar-Castillon P, Cenarro A, Civeira F. Impaired Sensitivity to Thyroid Hormones Is Associated With Diabetes and Metabolic Syndrome. Diabetes Care. 2019 Feb;42(2):303-310. doi: 10.2337/dc18-1410. Epub 2018 Dec 14.
PubMed 30552134Lakhani G, Patel P, Patel TC. A Cross-Sectional Study on the Prevalence of Subclinical Hypothyroidism in Metabolic Syndrome Patients at a Tertiary Care Hospital. Cureus. 2024 Aug 26;16(8):e67851. doi: 10.7759/cureus.67851. eCollection 2024 Aug.
PubMed 39323691Thakur R, Kumar S, Neeraj RK, Saleem M, Kumar C, Mohan L. Evaluation of the Association between Insulin Resistance and Subclinical Hypothyroidism Using Triglyceride-Glucose Index: a Cross-Sectional Study. Maedica (Bucur). 2024 Jun;19(2):255-259. doi: 10.26574/maedica.2024.19.2.255.
PubMed 39188835Verma DP, Chaudhary SC, Singh A, Sawlani KK, Gupta KK, Usman K, Reddy HD, Patel ML, Verma SK, Atam V. Hypothyroidism in Metabolic Syndrome. Ann Afr Med. 2024 Oct 1;23(4):717-722. doi: 10.4103/aam.aam_25_24. Epub 2024 Sep 14.
PubMed 39279179Xie H, Li N, Zhou G, He Z, Xu X, Liu Q, Wang H, Han J, Shen L, Yu P, Chen J, Chen X. The association between the thyroid feedback quantile-based index and serum uric acid in U.S. adults. Eur J Med Res. 2023 Jul 27;28(1):259. doi: 10.1186/s40001-023-01214-3.
PubMed 37501165Xie Y, Wang Z, Chen Z. Analysis of Subclinical Thyroid Dysfunction and Metabolic Abnormality in 28568 Healthy People. Int J Endocrinol. 2023 Oct 16;2023:5216945. doi: 10.1155/2023/5216945. eCollection 2023.
PubMed 37876378Zhong L, Liu S, Yang Y, Xie T, Liu J, Zhao H, Tan G. Metabolic syndrome and risk of subclinical hypothyroidism: a systematic review and meta-analysis. Front Endocrinol (Lausanne). 2024 Jun 25;15:1399236. doi: 10.3389/fendo.2024.1399236. eCollection 2024.
PubMed 38982986Di Bonito P, Corica D, Marzuillo P, Di Sessa A, Licenziati MR, Faienza MF, Calcaterra V, Franco F, Maltoni G, Valerio G, Wasniewska M. Sensitivity to Thyroid Hormones and Reduced Glomerular Filtration in Children and Adolescents with Overweight or Obesity. Horm Res Paediatr. 2024;97(4):383-387. doi: 10.1159/000534472. Epub 2023 Oct 9.
PubMed 37812927Calcaterra V, Mameli C, Macedoni M, De Silvestri A, Sgambetterra L, Nosenzo F, Redaelli FC, Petitti A, Bosetti A, Zuccotti G. Investigating the connection among thyroid function, sensitivity to thyroid hormones, and metabolic syndrome in euthyroid children and adolescents affected by type 1 diabetes. J Pediatr Endocrinol Metab. 2024 Mar 12;37(4):347-352. doi: 10.1515/jpem-2023-0565. Print 2024 Apr 25.
PubMed 38462926Calcaterra V, Gazzarri A, De Silvestri A, Madia C, Baldassarre P, Rossi V, Garella V, Zuccotti G. Thyroid function, sensitivity to thyroid hormones, and metabolic syndrome in euthyroid children and adolescents with Down syndrome. J Endocrinol Invest. 2023 Nov;46(11):2319-2325. doi: 10.1007/s40618-023-02086-4. Epub 2023 Apr 11.
PubMed 37040064Biondi B. Subclinical Hypothyroidism in Patients with Obesity and Metabolic Syndrome: A Narrative Review. Nutrients. 2023 Dec 27;16(1):87. doi: 10.3390/nu16010087.
PubMed 38201918Alwan H, Ribero VA, Efthimiou O, Del Giovane C, Rodondi N, Duntas L. A systematic review and meta-analysis investigating the relationship between metabolic syndrome and the incidence of thyroid diseases. Endocrine. 2024 May;84(2):320-327. doi: 10.1007/s12020-023-03503-7. Epub 2023 Sep 9.
PubMed 37688711
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Risk Assessment in Prepubertal Children With Congenital Hypothyroidism (IpoMet)
- ClinicalTrials.gov ID
- NCT07126353
- Acronym / sponsor ID
- IpoMet / CET 503-2024
- Conditions
- Congenital Hypothyroidism, Metabolic Syndrome
- Keywords
- Congenital hypothyroidism, metabolic syndrome, Obesity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Buzzi Children's HospitalUniversity, hospital or other
- Collaborators
- Federico II University, IRCCS Ospedale San Raffaele, Policlinico di Bari Giovanni XXIII, Azienda Ospedaliero Universitaria Policlinico Modena, Azienda Ospedaliero-Universitaria di Parma, Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna, Azienda Ospedaliera Sant'Anna, University Hospital Perugia, University of L'Aquila, Clinica Pediatrica Università di Novara, Santobono-Pausilpon Hospital, Azienda Ospedaliera Universitaria Policlinico "G. Martino", IRCCS Azienda Ospedaliero-Universitaria di Bologna, University Hospital of Ancona
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose a multicenter prospective study to define the prevalence and severity score of metabolic syndrome in a prepubertal pediatric cohort with congenital hypothyroidism, compared to a healthy and normal-weight pediatric population. These data will help to define whether hypothyroidism can be considered a risk factor for the metabolic health of the pediatric population. The possible identification of an at-risk metabolic profile will provide useful information to optimize the diagnostic and monitoring pathway for affected children.
Detailed description
Primary congenital hypothyroidism is the most common endocrine disorder in childhood and can present in either a permanent or transient form. Prolonged thyroid hormone deficiency can cause widespread damage affecting multiple organs and systems. Exposure to thyroid hormone deficiency during fetal and/or neonatal life has particularly severe consequences on the central nervous system, leading to neurocognitive delay. Appropriate and timely hormone replacement therapy (L-thyroxine) can prevent such outcomes, provided it is initiated early.
Thyroid hormones play a crucial role not only in growth and organ development but also in metabolic homeostasis. Thyroid function lies at the crossroads of multiple metabolic pathways. They have multiple effects on glucose and lipid metabolism, specifically by increasing glucose levels, fatty acid oxidation in muscle and liver, and lipolysis in adipose tissue. They also contribute to blood pressure regulation, thereby influencing the prevalence of metabolic syndrome, which is itself a key predictor of type 2 diabetes, cardiovascular diseases, and neurodegenerative conditions.Thyroid function plays a central regulatory role at the intersection of key metabolic pathways. Although, the role of thyroid hormones in metabolic processes is well established, and a bidirectional relationship between metabolic dysfunction and thyroid hypofunction has been reported in the adult population, data on metabolic risk in pediatric patients with congenital hypothyroidism are currently lacking.
The primary aim of this multicenter project is to assess the prevalence of metabolic syndrome in patients with congenital hypothyroidism and to determine whether this population presents a higher metabolic risk profile compared to the general population. As secondary objectives, this prospective study aims to:
- Define the prevalence and severity score of metabolic syndrome in a prepubertal pediatric cohort with congenital hypothyroidism, compared to a pediatric population with obesity.
- Evaluate the correlations between individual metabolic dysfunction parameters and the clinical and hormonal profile (including thyroid hormone levels and thyroid hormone sensitivity indices).
- Assess the correlations between the metabolic profile and renal function.
- Assess the correlations between the hormonal profile and renal function. To achieve these objectives, auxological parameters, vital signs (including blood pressure and heart rate), and metabolic profile data (glucose and lipid profiles, renal function, and hormonal status - FT3, FT4, TSH and thyroid hormone resistence indices TSHI, TT4RI, TT3RI, TFQI, PTFQI) will be collected for each enrolled subject. These parameters will be evaluated on peripheral blood samples collected during routine blood monitoring already scheduled according to established follow up. The potential presence of metabolic syndrome will be evaluated in each enrolled patient. The severity of the metabolic disorder will be evaluated using the Metabolic Score (MetS).
Data analysis will be performed using the statistical packages R 4.0.5 (R Core Team, 2021) and STATA (version 15.1, 2017, Stata Corporation, College Station, Texas, USA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Permanent congenital hypothyroidism | – | Other: prospective observational study (clinical, hormonal and auxological data)170 patients in prepubertal age. |
| Healthy childrens normal weight | – | Other: prospective observational study (clinical, hormonal and auxological data)170 childrens in prepubertal age. |
| Healthy childrens overweight/obese | – | Other: prospective observational study (clinical, hormonal and auxological data)170 patients in prepubertal age |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- We enrolled patients affected by permanent congenital hypothyroidism in prepubertal age and healthy childrens in prepubertal age to compare them with each other.
Key inclusion criteria (4 listed)
- Pubertal stage Tanner 1
- Permanent congenital hypothyroidism
- All ethnic groups
- Informed consent signature
Key exclusion criteria (3 listed)
- Age< 5 years
- Pubertal stage Tanner 2-5
- Transient congenital hypothyroidism or other type of hypothyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prospective observational study (clinical, hormonal and auxological data)We collect clinical, hormonal and auxological data and compare them between the two groups. | Other | Healthy childrens normal weight, Healthy childrens overweight/obese, Permanent congenital hypothyroidism |
Primary outcome
Metabolic syndrome (MS)
Time frame: At the time of enrollment
Presence of at least 3 of the following parameters: 1. BMI z-score ≥ 2 and/or waist-to-height ratio (WHtR) > 0.5 2. Fasting blood glucose ≥ 100 mg/dL and/or TryG index ≥ 7.88 3. Total cholesterol ≥ 200 mg/dL 4. HDL cholesterol < 40 mg/dL and/or LDL cholesterol ≥ 130 mg/dL 5. Triglycerides (TG) ≥ 100 mg/dL for ages 0-9 years; ≥ 130 mg/dL for ages >10 years 6. Systolic and/or diastolic blood pressure (SBP and/or DBP) ≥ 90th percentile for age and sex
Metabolic score (MeTs)
Time frame: At the time of enrollment
Males MetS z-score = -4.931 + 0.2804 * BMI z-score - 0.0257 * HDL + 0.0189 * SBP + 0.6240 * log(triglycerides) + 0.0140 * fasting glucose Females MetS z-score = -4.3757 + 0.4849 * BMI z-score - 0.0176 * HDL-C + 0.0257 * SBP + 0.3172 * log(triglycerides) + 0.0083 * fasting glucose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Background: PubMed 19226261Jostel A, Ryder WD, Shalet SM. The use of thyroid function tests in the diagnosis of hypopituitarism: definition and evaluation of the TSH Index. Clin Endocrinol (Oxf). 2009 Oct;71(4):529-34. doi: 10.1111/j.1365-2265.2009.03534.x. Epub 2009 Feb 18.
- Background: PubMed 35634497Iwamoto Y, Kimura T, Tatsumi F, Sugisaki T, Kubo M, Nakao E, Dan K, Wamata R, Iwamoto H, Takahashi K, Sanada J, Fushimi Y, Katakura Y, Shimoda M, Nakanishi S, Mune T, Kaku K, Kaneto H. Effect of Hyperglycemia-Related Acute Metabolic Disturbance on Thyroid Function Parameters in Adults. Front Endocrinol (Lausanne). 2022 May 12;13:869869. doi: 10.3389/fendo.2022.869869. eCollection 2022.
- Background: PubMed 27375554Dietrich JW, Landgrafe-Mende G, Wiora E, Chatzitomaris A, Klein HH, Midgley JE, Hoermann R. Calculated Parameters of Thyroid Homeostasis: Emerging Tools for Differential Diagnosis and Clinical Research. Front Endocrinol (Lausanne). 2016 Jun 9;7:57. doi: 10.3389/fendo.2016.00057. eCollection 2016.
- Background: PubMed 30552134Laclaustra M, Moreno-Franco B, Lou-Bonafonte JM, Mateo-Gallego R, Casasnovas JA, Guallar-Castillon P, Cenarro A, Civeira F. Impaired Sensitivity to Thyroid Hormones Is Associated With Diabetes and Metabolic Syndrome. Diabetes Care. 2019 Feb;42(2):303-310. doi: 10.2337/dc18-1410. Epub 2018 Dec 14.
- Background: PubMed 39323691Lakhani G, Patel P, Patel TC. A Cross-Sectional Study on the Prevalence of Subclinical Hypothyroidism in Metabolic Syndrome Patients at a Tertiary Care Hospital. Cureus. 2024 Aug 26;16(8):e67851. doi: 10.7759/cureus.67851. eCollection 2024 Aug.
- Background: PubMed 39188835Thakur R, Kumar S, Neeraj RK, Saleem M, Kumar C, Mohan L. Evaluation of the Association between Insulin Resistance and Subclinical Hypothyroidism Using Triglyceride-Glucose Index: a Cross-Sectional Study. Maedica (Bucur). 2024 Jun;19(2):255-259. doi: 10.26574/maedica.2024.19.2.255.
- Background: PubMed 39279179Verma DP, Chaudhary SC, Singh A, Sawlani KK, Gupta KK, Usman K, Reddy HD, Patel ML, Verma SK, Atam V. Hypothyroidism in Metabolic Syndrome. Ann Afr Med. 2024 Oct 1;23(4):717-722. doi: 10.4103/aam.aam_25_24. Epub 2024 Sep 14.
- Background: PubMed 37501165Xie H, Li N, Zhou G, He Z, Xu X, Liu Q, Wang H, Han J, Shen L, Yu P, Chen J, Chen X. The association between the thyroid feedback quantile-based index and serum uric acid in U.S. adults. Eur J Med Res. 2023 Jul 27;28(1):259. doi: 10.1186/s40001-023-01214-3.
- Background: PubMed 37876378Xie Y, Wang Z, Chen Z. Analysis of Subclinical Thyroid Dysfunction and Metabolic Abnormality in 28568 Healthy People. Int J Endocrinol. 2023 Oct 16;2023:5216945. doi: 10.1155/2023/5216945. eCollection 2023.
- Background: PubMed 38982986Zhong L, Liu S, Yang Y, Xie T, Liu J, Zhao H, Tan G. Metabolic syndrome and risk of subclinical hypothyroidism: a systematic review and meta-analysis. Front Endocrinol (Lausanne). 2024 Jun 25;15:1399236. doi: 10.3389/fendo.2024.1399236. eCollection 2024.
- Background: PubMed 37812927Di Bonito P, Corica D, Marzuillo P, Di Sessa A, Licenziati MR, Faienza MF, Calcaterra V, Franco F, Maltoni G, Valerio G, Wasniewska M. Sensitivity to Thyroid Hormones and Reduced Glomerular Filtration in Children and Adolescents with Overweight or Obesity. Horm Res Paediatr. 2024;97(4):383-387. doi: 10.1159/000534472. Epub 2023 Oct 9.
- Background: PubMed 38462926Calcaterra V, Mameli C, Macedoni M, De Silvestri A, Sgambetterra L, Nosenzo F, Redaelli FC, Petitti A, Bosetti A, Zuccotti G. Investigating the connection among thyroid function, sensitivity to thyroid hormones, and metabolic syndrome in euthyroid children and adolescents affected by type 1 diabetes. J Pediatr Endocrinol Metab. 2024 Mar 12;37(4):347-352. doi: 10.1515/jpem-2023-0565. Print 2024 Apr 25.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Hypothyroidism and Metabolic Syndrome, run by Buzzi Children's Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valeria Calcaterra, MD (+39 0263631, valeria.calcaterra@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic syndrome (MS) (time frame: At the time of enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07126353, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.